High suicide rates related to anti-smoking
drug Chantix were 'left out of crucial safety review'
Hundreds of reports of suicides and violent reactions
tied to the stop-smoking drug Chantix were left out of a crucial government
safety review.
The reports were missing because the drug’s
manufacturer Pfizer Inc. submitted years of data through 'improper channels',
according to the Food and Drug Administration.
Serious problems — such as people killing themselves,
trying to kill themselves, depression and unprovoked attacks on others — were
mixed among 26,000 records of non-serious side effects such as nausea and rashes
dating back to 2006, the year Chantix, or varenicline, was
approved.
Controversial chemicals: Chantix is
regarded as one of the 'riskiest' drugs by some
scientists
Cases of 150 suicides, more than doubling those
previously known, were among 589 delayed reports of severe issues uncovered in
new analysis by the Institute for Safe Medication Practices
(ISMP).
Thomas J Moore, the senior scientist who analysed the
data for the non-profit ISMP, said: 'It’s really chilling. This seems to unleash
something in people. It can be violence to anything around. We’ve had a major
breakdown in safety surveillance.'
His analysis echoes previous horror stories that
Chantix can induce extreme reactions in people trying to quit cigarettes,
including vivid nightmares, crippling depression and violent
outbursts.
Federal Food and Drug Administration officials said
that they asked Pfizer to resubmit thousands of records after realising that the
company was sending required reports in an inappropriate format that could not
be added to the agency’s Adverse Events Reporting System, or AERS.
The agency said: 'Last year, the FDA became aware that
a few manufacturers were submitting adverse events reports to FDA through
improper channels.'
Pfizer officials said they were submitting reports as
required and that when the FDA asked them to change, they did so immediately.
But they added that there's no proof that Chantix causes suicide or other
serious side effects.
Mr Moore, who has served as an expert witness in court
cases related to Chantix, said it is the riskiest drug among those analysed from
the FDA's adverse event reports, msnbc.com
reports.
In the third quarter of 2010, it ranked first in
reported deaths, with twice as many fatalities logged as any other drug, he
said.
Moore, who has served as an expert witness in court
regarding Chantix, said it's the riskiest drug among those analysed from the
FDA's adverse event reports.
In the third quarter of 2010, it ranked first in
reported deaths, with twice as many fatalities logged as any other drug, he
said.
FDA officials said the new reports did not change the
agency’s position on the risks and benefits of the controversial drug, which
received a black box warning that included suicide — the strongest caution
possible — in 2009.
Agency officials said they are continuing to review
Chantix in clinical trials.
But Mr Moore said the new data should raise immediate
alarms about the drug that was prescribed 3.2 million times last year to people
trying to stop smoking — and 1.1 million times already this
year.
He said: 'To us, it raises questions about whether this
drug is safe for widespread clinical use.'
Pfizer officials said that the firm was following the
FDA's rules and changed their reporting process once the agency asked for
clarification.
The company said: 'All post-marketing reports of
adverse events are reviewed by Pfizer and reported to regulators, including FDA,
in accordance with regulatory guidelines.
'Pfizer takes patient safety and regulatory reporting
obligations very seriously.'
The FDA requires drugmakers to submit adverse events in
two ways.
There’s an 'expedited' system that requires companies to report
serious and unexpected adverse events into the AERS system within 15
days.
Then there's the less-serious and expected adverse
events to be submitted quarterly in so-called 'periodic
reports.'
In those cases, problems previously included on drug
labels — including suicide and suicide attempts — are considered to be expected
events.
In Pfizer’s case, the firm was submitting the periodic
reports as required, but combining summaries and individual case reports in a
single text file, the FDA said.
That meant that the individual reports of injury were
not logged in the FDA’s AERS system, drastically reducing known reports of
suicides and other psychiatric problems tied to Chantix, Mr Moore
said.
He said: 'It’s very clear the suicide risk of this drug
was higher than we knew.'
Overall, there were 1,055 reports of serious problems
with Chantix reported in the third quarter of 2010, more than any other
prescription medication regularly monitored by the drug safety agency, Mr Moore
added.
Before last July, the FDA had logged 122 reports of
suicides linked to Chantix, including 37 reported by Pfizer and 85 reported by
health professionals or consumers.
After the 150 new Pfizer reports were added, the total
jumped to 272.
In addition, the 589 new reports of severe problems
included 102 cases of possible hostility and aggression, 156 cases of depression
and 56 cases of possible psychosis.
Those were mixed among the 26,000 reports of
less-serious problems.
Mr Moore has asked the FDA to investigate the 150 new
suicide reports, particularly if the events occurred before the 2009 black box
warning listed suicide as a possible side effect.
FDA officials said they are considering changing
regulations to allow expedited reports of suicides and other serious problems,
even if they’ve previously been identified as
expected.
